The Accelerated Aging protocol ASTM F1980 was updated in late December 2021. What changed? Are you affected?
For starters, the new revision, ASTM F1980-21, adds the medical device and its components to the Accelerated Aging protocol, which previously focused on SBS integrity.
The ASTM F1980 revision requires that device manufacturers examine the impact of moisture on their products and package materials and consider that when determining the Accelerated Aging temperature and humidity inputs.
If it is determined there is no moisture impact, Accelerated Aging can be performed with uncontrolled humidity; a justification should be written.
Protocol updates are significant at WESTPAK. We’re on top of this one and ready to support your team.